20+ years of Supporting Life Sciences
With the estimated cost of bringing a drug to market at $2.5 billion and the probability of success of getting to the market from phase 1 at less than 10%, clinical operations have never faced a more challenging environment than now.
While a typical phase 3 trial generates 900,000 data points, many companies still rely on Excel spreadsheets to bring data together from traditionally silo-ed sources. This takes time which limits the ability to drive decisions off clinical data in real time.
Monitoring services predominantly rely on routinely scheduled site visits to verify source data, resulting in high travel costs, and inefficient processes. 100% source data verification accounts for up to 25% of trial costs. However, it does not contribute to data quality value, instead alternative, risk based, approaches can benefit patient safety without such a significant cost contribution.
Inspection findings reflect this complex picture, with critical findings from EMA, MHRA and FDA focused on the following areas:
- Data capture, clean-up, analysis, integrity and management
- Risk based monitoring
- Sponsor trial management and CRO oversight
- TMF, QMS and essential document management
Reflecting these findings, the ICH GCP guidelines have been revised in 2017, thereby adding a further compliance challenge for clinical operations.
Top-level Clinical Strategy Challenges
Making the clinical trial
recruitment process robust, and compliant for the sponsor whilst being easy for the patients
data sources, eliminating inefficient processes, reducing source data verification
Adapting to risk
based and adaptive
or improving compliance
Navitas Life Sciences Creates Impactful Results for Sponsors Through an Integrated Approach
Our global clinical consultants apply their extensive expertise and knowledge to guide sponsors to achieve their strategic objectives through best practices. With over 20 years of experience of supporting Life Sciences companies, breakthrough insights gained through our industry network forums, models for success, and proven structured approaches, Navitas Life Sciences serves as a trusted strategic advisor.
Trusted Strategic Advisor
Global Team of Consultants
Insights through Proprietary Industry Networks
Proven Models for Success
Our breadth and depth of experience has taught us that there is no one-size-fits-all solution. We take a personalized approach to each client situation to ensure results are grounded in industry best-practices, but tailored to specific needs, fit-for-purpose, cost-effective, scalable, and compliant. Engagements begin with a detailed current state assessment to prioritize improvement opportunities and continue beyond pragmatic recommendations to include detailed solution design and implementation. This includes managing the change, developing / revising controlled documents, incorporating revised responsibilities into role descriptions, and developing training plans and materials for roll-out across functional stakeholders.
By including our clients’ subject matter experts, who have deep institutional knowledge, prominently on project teams, improvements are implemented smoothly to ensure project benefits continue to be realized beyond the end of our contractual engagement.
Transformation to Risk Based Monitoring
ICH E6 GCP Health check, Support for Inspection Readiness